International Impact of Vaccine Safety Concerns Learning the hard way for 20 years

Lessons from the plasma derived HB vaccine “This vaccine may be crawling with AIDS virus…” The concern was quickly addressed scientifically but public never heard this The issue of safety of plasma derived vaccine never went away (but the vaccine did) seriously delayed HB introduction in many countries exploited by industry for marketing purposes

First big lesson Many of these issues will never go away will have to be managed like a chronic illness with periodic flare-ups It is much easier to break an egg than to put a broken egg back together

Bad stuff happens –children die from vaccines and programmatic mistakes Increasing energy and resources go into dealing with anti-vaccination ideas anti-vaccination ideas cross borders –may follow linguistic boundaries –medical leaders trained abroad –influenced by training but often out of date local ideas may generate problems Philippines and sterilization from TT More lessons

Anti-vaccination groups and individuals extremely diverse parents with legitimate concerns religious (pork, fetal tissue, “if God wanted…”) “alternative medicine”, granola types conspiracy theories (sterilization, HIV) “the government can’t tell me what to do” lawyers and others with financial or political agendas scientists who report hypotheses in media opinionated media

What happens in industrial countries has ramifications in developing countries –OPV –thimerosol: huge implications –acellular pertussis –rotavirus IOM is part of the problem: There are insufficient data to confirm or deny an association……. Good news is of little interest to media –scientific hypotheses may take years to confirm or deny, media wants answers in 20 minutes More lessons

Pharmaceutical companies implying competing vaccines are unsafe: a losing strategy for everyone Clinical trials can trigger anti-vacc ideas –Guinea pigs –ethical dilemmas –political agendas (HEV Nepal, HB St. Kitts) Real issues such as unsafe injections arouse little interest

Injection Safety ~16 billion injections/year ~33% unsafe in developing countries ~20 million HBV infections/yr + ~2 million HCV and ~260,000 HIV infections Little change until GAVI and SIGN Fund eligible countries get auto-disable syringes for 3 years. 200 million already distributed Countries responsible for national plan, training, waste management Major GAVI gift to wider HC community

Shifting sands of causality Belief: MMR causes autism (Hx 1) it is antigen #1 DATA OK maybe its not antigen#1, its (Hx 2) giving the antigens together DATA OK maybe its not giving antigens together (Hx 3) it’s the preservative

Nocebo effect If a positive belief in the effectiveness of a therapy can have positive effects (placebo effect ~ 30%), can a negative belief in the safety of a therapy have negative effects? look at France

13 step recovery program No vaccine is 100% effective all vaccines have side effects decision to use or not use based on considering balance between benefits and risks (and on cost effectiveness) disease burden before immunization known risk of vaccine benefit/risk ratio hugely in favor of vaccines

13 step recovery program diseases do return when immunization stops surveillance systems for adverse events by in large work and are able to pick up even rare events research is done to investigate hypotheses of safety problems vaccines are removed or changed when safety concerns are found to be valid

13 step recovery program there are many (chronic diseases) of unknown etiology where vaccines are one of many possible causes we do not stop immunization while we investigate each hypothesis inform where to go for more (reliable) information

What to do become familiar with the issues media training cultivate media leaders know where to get helpful information call for help in investigating local incidents